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Evoke SCS
SALUDA MEDICAL Evoke SCS Clinical Manual
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Evoke
®
SCS System
Clinical Manual
CLIN
-
UMAN
-
005175
Revision:
9.00
Page
1
of
101
Ev
o
ke
®
SCS Sy
s
tem Clinical Manual
Use of the Evoke
Cli
nical Interface
(CI) and
Clinical Progra
mming
Application
(CPA)
with t
he Evoke Clinic
al System Trans
c
e
i
ver (CST)
for
programming
the Evoke
SCS System
2
Table of Contents
Table of Contents
2
Description
5
The Concept of ECAP-Controlled Closed-Loop SCS
5
Stimulation Features
5
Measurement Features
6
System Components
8
Indication for Use
10
Contraindications
10
Safety Information
10
Precautions
10
Introduction
12
Evoke Clinical Interface (CI)
12
Evoke Clinical System Transceiver (Cst)
12
Clinical Interface - General Programming Using the Cpa
13
Connecting the CI to the Cst and Ecls/Cls
13
Set Stimulator Time
15
Check Stimulator Battery Voltage
16
Retrieve or Set the Patient ID and Patient Zone
16
Measure Electrode Impedances
18
Set up Lead Orientation
19
Programming Overview
20
Choose the Stimulation Electrodes Automatically
20
Start and Stop Stimulation with Closed-Loop Disabled
21
Set up Ecap Measurement
23
Set up Closed-Loop Stimulation
29
Set Appropriate Limits and Increments
30
Enable Closed-Loop Stimulation
31
Start and Stop Stimulation with Closed-Loop Enabled
33
Save a Program to the Stimulator
34
Create a New Program or Use Programming Features and Settings
36
Disconnect from the Stimulator and Close the Cpa
36
Clinical Interface - Programming Features
37
Stimulation Waveform
37
Clearcap
38
Current Steering
39
Measurement Electrode Scan
40
Interleaved Stimulation
45
Activation Plot Levels
49
Data Files
50
Neurophysiological Measurements
51
Additional Impedance Measurements
57
Patient Survey
57
Clinical Interface - Settings Guide
59
Stimulation Settings Menu
59
Measurement and Feedback Settings Menu
60
Electrode Selection Modes
61
Cls Menu
62
Navigation Menu
65
Settings Screen
65
Alert and Error Display
68
Intra-Operative Programming with the CI
70
Connect the Intraoperative Cable to the Ecls
70
Confirm Optimal Lead Placement
71
Confirm Cls Connection
72
Post-Operative Programming Procedures
73
Prepare the Ecls for the Trial Stimulation Period
73
Connect the Lead or Lead Extension to the Lead Adapter
73
Connect the Lead Adapter to the Ecls
75
Place the Ecls into the Case
76
Charge the Ecls Battery
76
Secure the Ecls for the Trial Stimulation Period
77
Behaviour of the Stimulator When Alerts Occur
77
Out of Compliance
77
Reference Clock Error
78
Electrode Disconnected
78
Current at Maximum
78
Clipping
78
Evoke Patient Controller
79
Pair Epc to Stimulator
79
Evoke Charger
80
Stimulation During Charging
80
Patient Education and ID Card
81
Maintenance of the Evoke CI and Evoke Cst
82
Maintenance of the Evoke CI
82
Maintenance of the Evoke Cst
82
Updating the Evoke CI Software
82
Disposal of Devices
83
Troubleshooting
83
Package Contents
87
Technical Specifications
87
Device Specifications
87
Wireless Communication
89
Electromagnetic Interference
89
Federal Communications Commission (Fcc)
93
Glossary
94
Symbols
99
Contact Us
101
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SALUDA MEDICAL Evoke SCS Specifications
General
Brand
SALUDA MEDICAL
Model
Evoke SCS
Category
Medical Equipment
Language
English
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